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DESCRIPTIONThis policy addresses the use of electrical stimulation of the dorsal columns by implantation of electrodes in the epidural space as a treatment of chronic pain. The neurophysiology of pain relief after spinal cord injury is uncertain, but may be related to either activation of an inhibitory system or blockage of facilitory circuits. Spinal cord stimulation devices consist of implantable electrodes and receiver/transducer and a programmable transmitter that may be worn externally or may be fully implanted.
Spinal cord stimulation delivers low voltage electrical stimulation to the dorsal columns of the spinal cord to block the sensation of pain. Spinal cord stimulation devices consist of several components: 1) the lead that delivers the electrical stimulation to the spinal cord; 2) an extension wire that conducts the electrical stimulation from the power source to the lead, and 3) a power source that generates the electrical stimulation. The lead may incorporate from 4 to 8 electrodes, with 8 electrodes more commonly used for complex pain patterns, such as bilateral pain or pain extending from the limbs to the trunk. There are two basic types of power source. In one type, the power source (battery) can be surgically implanted. In the other, a radiofrequency receiver is implanted, and the power source is worn externally with an antenna over the receiver. Totally implantable systems are most commonly used.
Spinal cord stimulation has been used in a wide variety of chronic refractory pain conditions, including pain associated with cancer, failed back pain syndromes, arachnoiditis, and complex regional pain syndrome (i.e., chronic reflex sympathetic dystrophy). There has also been interest in spinal cord stimulation as a treatment of critical limb ischemia, primarily in patients who are poor candidates for revascularization, and in patients with refractory chest pain. The neurophysiology of pain relief after spinal cord stimulation is uncertain, but may be related to either activation of an inhibitory system or blockage of facilitative circuits.
The patient’s pain distribution pattern dictates at what level in the spinal cord the stimulation lead is placed. The pain pattern may influence the type of device used; for example, a lead with 8 electrodes may be selected for those with complex pain patterns or bilateral pain. Implantation of the spinal cord stimulator is typically a 2-step process. Initially, the electrode is temporarily implanted in the epidural space, allowing a trial period of stimulation. Once treatment effectiveness is confirmed (defined as at least 50% reduction in pain), the electrodes and radio-receiver/transducer are permanently implanted. Successful spinal cord stimulation may require extensive programming of the neurostimulators to identify the optimal electrode combinations and stimulation channels. Computer-controlled programs are often used to assist the physician in studying the millions of programming options when complex systems are used.
A number of total implanted spinal cord stimulators have received U.S. Food and Drug Administration (FDA) premarket approval (PMA). The Cordis programmable neurostimulator from Cordis, Corp. was approved in 1981 and the Itrel(R) manufactured by Medtronic was approved in 1984. In April 2004, Advanced Bionics received PMA for its Precision spinal cord stimulator as an aid in management of chronic, intractable trunk and limb pain. All are fully implanted devices.
Spinal Cord Stimulation (SCS) for the Treatment of Intractable Angina Pectoris is addressed in a separate policy.
Deep Brain Stimulation of the thalamus as a treatment of tremor is addressed in a separate policy.
POLICYSpinal cord stimulation may be considered medically necessary for the treatment of severe and chronic pain of the trunk or limbs that is refractory to all other pain therapies after a trial period as outlined in the Policy Guidelines.
Spinal cord stimulation is considered investigational as a treatment of critical limb ischemia as a technique to forestall amputation and as a treatment for refractory angina pectoris.
POLICY EXCEPTIONSFederal Employee Program (FEP) may dictate that all FDA-approved devices, drugs or biologics may not be considered investigational and thus these devices may be assessed only on the basis of their medical necessity.
POLICY GUIDELINESPatient selection focuses on determining whether or not the patient is refractory to other types of treatment. The following considerations may apply.
Investigative service is defined as the use of any treatment procedure, facility, equipment, drug, device, or supply not yet recognized by certifying boards and/or approving or licensing agencies or published peer review criteria as standard, effective medical practice for the treatment of the condition being treated and as such therefore is not considered medically necessary.
The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.
3/2001: Policy reviewed; Hyperlinks inserted under Policy, Managed Care Requirements deleted, Sources updated
2/15/2002: Investigational definition added
3/6/2002: Individual consideration requirement deleted
5/7/2002: Type of Service and Place of Service deleted
10/26/2005: Code Reference section updated; CPT-4: 63660 added; ICD-9 Procedure: 02.93 deleted; 03.94, 86.94, 86.95, 86.96 added; HCPCS: E0752, E0754 added
11/15/2005: ICD9 procedure codes 86.97, 86.98 added
3/14/2006: Coding updated. HCPCS 2005 & 2006 revisions added to policy
4/1/2008: Policy reviewed, no changes
12/31/2008: Code reference section updated per 2009 CPT/HCPCS revisions
1/8/2009: Policy reviewed, no changes
12/16/2009: Coding Section revised for 2010 CPT4 and HCPCS revisions
04/27/2010: Policy description re-written extensively to provide information on various conditions spinal cord stimulation is used for, FDA status of devices, and techniques for device placement. Policy statement updated to add “and as a treatment for refractory angina pectoris” to the investigational statement. Patient selection criteria added to the policy guidelines. FEP verbiage added to the Policy Exceptions section. Deleted outdated references in the Sources section.
04/18/2011: Policy description and statement unchanged. Removed deleted CPT code 63660 from the Code Reference section.
03/02/2012: Policy reviewed; no changes.
04/04/2013: Policy reviewed; no changes to policy statement. Added ICD-9 procedure code 86.05 to the Code Reference section.
SOURCE(S)Blue Cross & Blue Shield Association policy # 7.01.25
CODE REFERENCEThis may not be a comprehensive list of procedure codes applicable to this policy.
The code(s) listed below are ONLY medically necessary if the procedure is performed according to the "Policy" section of this document.